1. Introduction
1.1 Objective
1.2 Scope and applicability
1.3 Facility goal
2. Concepts and regulatory philosophy
2.1 Product and process requirements
2.2 Critical process steps
2.3 Protection of the product
2.4 Cross contamination and potent product issues
2.5 Aseptic processing area
2.6 Integrated facility design
2.7 Terminology for manufacturing areas and HVAC
2.8 Barrier-isolator technology
2.9 Other considerations
2.10 Good engineering practice, direct impact systems and indirect impact systems
3. Product and equipment considerations
3.1 Introduction
3.2 Process description
3.3 Alternative technologies
3.4 Equipment integration
3.5 Equipment – technical considerations
3.6 Considerations for equipment selection
4. Architecture and layout
4.1 Introduction
4.2 Design criteria
4.3 Layout considerations
4.4 Room function
4.5 Surface finishes & materials of construction
4.6 Transfer zones
5. HVAC
5.1 Introduction
5.2 Sources of particulate contamination
5.3 Environmental standards and GMP
5.4 Room relative pressure
5.5 HVAC system design
5.6 System filtration levels
5.7 Monitoring
6. Utility systems
6.1 Introduction
6.2 Descriptions and general considerations
6.3 Specific service considerations
7. Electrical
7.1 Introduction
7.2 General requirements
7.3 Power distribution
7.4 Lighting
7.5 Hazardous environments
7.6 Wiring
7.7 Door interlocks
7.8 Outlets and miscellaneous equipment
8. Control and instrumentation
8.1 Introduction
8.2 GMP critical environmental parameters
8.3 Production process parameters
8.4 Instrumentation
8.5 Electrical installation
8.6 General design issues
8.7 HVAC
9. Cleaning: engineering issues
9.1 Manual cleaning for equipment and facility
9.2 Semi-automatic cleaning
10. Barrier-isolator technology
10.1 Introduction
10.2 Barrier-isolator type
11. General considerations
11.1 Introduction
11.2 Environmental – air
11.3 Environmental – waste water
11.4 Environmental – noise
11.5 Environmental – solid and concentrated wastes
11.6 Health and safety
11.7 Site selection and location
11.8 Energy sources
11.9 Auditing, monitoring and reporting
11.10 Security
12. Commissioning & qualification
12.1 Introduction
12.2 Philosophy
12.3 Commissioning & qualification phases related to the stage gate process
12.4 Commissioning, qualification, & validation specific requirements
13. Appendix 1 – references
13.1 Overview of the standardization process
13.2 Standards
13.3 General references
13.4 Gowning philosophy
13.5 Conceptual diagrams and requirements table
13.6 HVAC diagrams
13.7 Electrical references
13.8 Instrumentation and controls references
14. Appendix 2 – HVAC European considerations
14.1 Introduction
14.2 Key differences to U.S. standards
15. Appendix 3 – HVAC – additional engineering information
15.1 Introduction
15.2 Sources of particulate contamination
15.3 HVAC design principles
15.4 Calculation of air change rate
15.5 Process impact
15.6 HVAC system design
15.7 Air handling unit (AHU) design considerations
15.8 Horizontal vs vertical unidirectional airflow
| Duration | 3 days |
| Language | English |
| Participants | 8 - 15 |
| Fees |